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Preleukemia clinical trials

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NCT ID: NCT03824080 Completed - Clinical trials for Acute Myeloid Leukemia

Evaluating the Efficacy and Safety of Bemcentinib in Patients With Myelodysplastic Syndromes

Start date: December 20, 2018
Phase: Phase 2
Study type: Interventional

This is an open-label, single-arm multicenter, phase II study. The primary objective is to assess the efficacy of bemcentinib (BGB324) a highly selective inhibitor of the AXL receptor tyrosine kinase for the treatment of AML and MDS patients failing or being refractory to first line hypomethylating agent (HMA) treatment. Furthermore, safety, disease progression, treatment failure will be assessed. A total of 43 patients will be included in the trial.

NCT ID: NCT03814005 Completed - Neoplasms Clinical Trials

A Study of Pevonedistat in People With Blood Cancers or Solid Tumors With Kidney or Liver Problems

Start date: July 10, 2019
Phase: Phase 1
Study type: Interventional

Pevonedistat is a medicine to treat people with blood cancers or solid tumors. The main aim of the study is to learn about the levels of pevonedistat in the blood of participants with blood cancers or solid tumors, who also have severe kidney problems or mild to moderate liver problems. The information from this study will be used to work out the best dose of pevonedistat to give people with these conditions in future studies. At the first visit, the study doctor will check who can take part in the study. This study is in 2 parts: A and B. Part A Participants will be placed into 1 of 4 treatment groups depending on how severe their kidney and liver problems are. All participants will receive 1 dose of pevonedistat as a slow injection in their vein (infusion). Then, the study doctors will check the levels of pevonedistat in the blood of the participants for 3 days after the infusion. They will also check if the participants have any side effects from pevonedistat. Participants will be asked to continue to Part B. Those who don't want to continue will visit the clinic 30 days later for a final check-up. Part B Participants who agree to participate into Part B will receive an infusion of pevonedistat on specific days during a 21-day or 28-day cycle. The cycle time will depend on what type of cancer the participants have. Participants will also be treated with standard of care medicines for their kidney and liver problems during this time. In the first cycle, the study doctors will also check the levels of pevonedistat in the blood and urine of participants for 3 days after the infusion. Participants will continue with cycles of treatment together with standard of care medicines until their condition gets worse or they have too many side effects from the treatment. When treatment has finished, participants will visit the clinic 10 days later for a final check-up.

NCT ID: NCT03813186 Completed - Clinical trials for Acute Myeloid Leukemia

Effect of Food on Blood Levels of ASTX727

Start date: November 8, 2018
Phase: Phase 1
Study type: Interventional

This study is designed to examine blood levels of ASTX727, a fixed-dose combination tablet containing the combination of cedazuridine (100 mg) and decitabine (35 mg), when given under fed versus fasted conditions to participants with myelodysplastic syndromes (MDS), including refractory anemia with excess blasts in transformation or chronic myelomonocytic leukemia (CMML), or acute myeloid leukemia (AML). This study will also assess the safety of ASTX727.

NCT ID: NCT03813147 Completed - Clinical trials for Refractory Acute Myeloid Leukemia

Pevonedistat, Azacitidine, Fludarabine Phosphate, and Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

Start date: May 17, 2019
Phase: Phase 1
Study type: Interventional

This phase I trial studies the side effects and how well pevonedistat, azacitidine, fludarabine phosphate, and cytarabine work in treating patients with acute myeloid leukemia or myelodysplastic syndrome that has come back (relapsed) or has not responded to treatment (refractory). Pevonedistat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as azacitidine, fludarabine phosphate, and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) and pevonedistat may work better in treating patients with acute myeloid leukemia or myelodysplastic syndrome.

NCT ID: NCT03787498 Completed - Clinical trials for High-risk Myelodysplastic Syndrome (MDS)

A Study of PLX2853 in Relapsed or Refractory Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome

Start date: March 19, 2019
Phase: Phase 1
Study type: Interventional

The purpose of this research study is to evaluate safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of the investigational drug PLX2853 in subjects with Relapsed or Refractory Acute Myeloid Leukemia or High-risk Myelodysplastic Syndrome

NCT ID: NCT03746041 Completed - Clinical trials for Myelodysplastic Syndromes

A Phase I Pilot Study of Abaloparatide + Bevacizumab in Myelodysplastic Syndromes

Start date: February 14, 2019
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to determine the safety and tolerability of combined abaloparatide and bevacizumab in patients with Myelodysplastic Syndromes (MDS). A secondary objective is to determine the response to treatment (based on bone marrow and peripheral blood findings). A tertiary objective is to determine the impact of therapy on health-related quality of life (HRQOL) and patient-reported outcomes (PRO). A quaternary (scientific) objective is to determine the impact of treatment on both hematopoietic and stromal cell populations within the bone marrow of MDS patients.

NCT ID: NCT03745716 Completed - MDS Clinical Trials

APR-246 & Azacitidine for the Treatment of TP53 Mutant Myelodysplastic Syndromes (MDS)

Start date: January 11, 2019
Phase: Phase 3
Study type: Interventional

A Phase III, multicenter, randomized study to compare the rate of complete response (CR) and duration of CR, in patients with TP53-mutated MDS who will receive APR-246 and azacitidine or azacitidine alone.

NCT ID: NCT03660228 Completed - Clinical trials for Myelodysplastic Syndromes

Peri-Transfusion QOL Assessments (PTQA): A New Paradigm of Transfusion Decision Support for Patients With MDS

Start date: October 17, 2018
Phase: N/A
Study type: Interventional

This research study is evaluating how to best tailor blood transfusion decisions to match the quality of life changes experienced by individual patients with MDS.

NCT ID: NCT03613727 Completed - Myelodysplasia Clinical Trials

Therapeutic Use of Intravenous Vitamin C in Allogeneic Stem Cell Transplant Recipients

Start date: October 1, 2018
Phase: Phase 2
Study type: Interventional

This phase 2 trial studies the effect of intravenous (IV) vitamin C repletion after myeloablative allogeneic stem cell transplant.

NCT ID: NCT03598582 Completed - Clinical trials for Myelodysplastic Syndromes

Biological Predictive Factors of Response to ESA in Low Risk MDS Patients

Start date: January 1, 2013
Phase: Phase 4
Study type: Interventional

In this trial, the investigators would like to understand why a small percentage of patients will be refractory to ESA (independently of International prognostic scoring system (IPSS) and % of blasts). In a retrospective study of the "Groupe Francophone des Myélodysplasies (GFM)" , the investigators showed that about 43% of patients are refractory or will relapse after initial response to ESA and it has been shown that these patients have a poorer survival. The investigators plan to give a 12-week treatment of Epoetin alfa or zeta in low risk MDS patients and measure different biological factors to predict response to ESA: - evaluation by flow cytometry before and after treatment of the degree of dyserythropoiesis and dysgranulopoiesis which could explain the primary resistance or loss of response of a subset of patients, - screening by molecular biology of predictive factors of response to ESA, - Iron homeostasis will be measured via hepcidin, GDF-15 and ferritin levels.